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Against the backdrop of crackdown on illegal sale of immunoglobulin injections meant for Rajasthan government hospitals, the Maharashtra Food and Drug Administration (FDA) has sent a proposal to the Drugs Controller General of India (DCGI) for inclusion of special marking or color-coding of medicines specifically supplied to government healthcare institution as a track and trace strategy.
“The proposal has also been submitted to the Directorate of Medical Education and Research (DMER), Maharashtra for approval and further action,” according to Maharashtra FDA Commissioner Dr Pallavi Darade.
Immunoglobulin injections were manufactured and packaged by Navi Mumbai-based Reliance Life Sciences (RLS) for Rajasthan government hospital supplies but were clandestinely smuggled in parts of Mumbai, Thane, Kolkata, Gwalior and Indore last year.
Based on the investigations carried out, Maharashtra FDA has filed FIRs against 11 persons involved in trading immunoglobulin injections in the open market at prices as high as Rs.20,000 per vial against the MRP of Rs.14,697 available in the retail trade.
Immunoglobulins are proteins that play an important role in body’s immune system and is also used for auto-immune diseases and cancers. The drug is prepared from human plasma in which natural antibodies are extracted from pooled plasma through a combination of traditional and contemporary methods.
Besides distributors in Kolkata and Indore, Mumbai based distributors listed in FIR include Chembur-based Shri Siddhivinayak Agency, Mediaxa Pharma of Dadar, Perfect Healthcare of Parel, Aniket Pharmaceuticals of Fort, Pacific Healthaxis of Dadar, Mediwell Health of Parel and Mapchem Pvt Ltd, Santacruz.
Investigations of the state FDA which started last year blew the lid off the illegal supply chain of trading the life-saving drug. RLS company officials last year came to know that unauthorised people were selling the drug under the brand name Immunorel in a clandestine manner.
“Based on the tip off, investigations were carried out and FIRs launched. The offenders have been charged under Indian Penal Code (IPC) sections for cheating and forgery and relevant sections of Drugs and Cosmetics (D&C) Act,” Dr Darade informed.
The investigations started when FDA officials from Thane branch were hinted about the buying and selling of the intravenous injection with tampered labels in a clandestine manner by RLS officials.
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